Wound closure apparatus and method

ABSTRACT

A wound closure apparatus can be a self-contained device for delivery and deployment of a tissue engineered wound plug that can secure fascial closure of laparoscopic port-site wounds. The wound plug can include a subfascial rivet head, a suprafascial rivet head, and a compressible column. Once in the wound, the wound plug may be deployed with the subfascial rivet head below the fascia of the wound and the suprafascial rivet head above the fascia of the wound. As this occurs, the column of the wound plug can be stationed within the opening of the wound. Once the wound plug is secured above, below, and within the fascial defect, the rivet heads may be interlocked within an inner channel of the column and remaining elements of the apparatus may be removed and discarded.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims priority to U.S. Non-Provisional patentapplication Ser. No. 14/634,421 filed Feb. 27, 2015 and published onSep. 1, 2016 as U.S. Patent Publication No. 2016-0249896, which ishereby incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to a wound closure apparatusand method.

BACKGROUND OF THE DISCLOSURE

Minimally invasive surgery (MIS), also referred to as laparoscopic orendoscopic surgery, has experienced spectacular growth worldwide overthe past few decades for the diagnosis and treatment of a variety ofacute and chronic pathologies. Endoscopic procedures are economical,safer, and promote a more rapid recovery in contrast to conventionalsurgical approaches. Technological advancements in MIS are expected tohave robust growth in the future. As endoscopic technologies develop andbecome the standard of care for most types of surgical interventions,the continued development of innovative quality tools to address theunique problems associated with this type of surgery must be vigorouslypursued.

A laparoscopic surgery is performed by inserting a cannula (a hollowplastic or metal tube) through the abdominal wall, either by scalpeldissection or by blunt penetration with a piercing instrument (a trocar)occupying the central lumen of the cannula. When the cannula is placedthrough the skin and into the abdomen, the surgical blade or centraltrocar is withdrawn, leaving a cannula that is designed to inflate theabdominal cavity with carbon dioxide gas in order to distend theanterior abdominal wall away from the internal organs. The presence ofthis gas in the abdominal cavity is known as a pneumoperitoneum.

Once the pneumoperitoneum is established, a fiber optic endoscope (whichmay either be attached to a high-definition video camera or guided bydirect vision) is inserted safely into the abdomen allowingvisualization of the abdominal viscera. When complete visualization ofthe abdomen is accomplished, a number of secondary cannulae are placedvia the previously described technique. The surgery is then performedthrough these cannulated passageways, referred to as ports. The portsfunction as conduits for the insertion and exchange of variousspecialized hand-held or robotic-assisted instruments and devices toaccomplish the laparoscopic procedure, which would otherwise beperformed by an open surgical incision.

The observed benefits of MIS include reduced blood loss, lower risk ofinfection, more rapid recovery rates, and reduced postoperative pain.These benefits have caused laparoscopy to become the preferred methodfor an ever-increasing number of surgical procedures. As with any othersurgery, however, MIS is not without its share of complications. Twocommon complications relevant to MIS surgeries are the formation ofabdominal adhesions and/or hernia development.

While laparoscopic adhesion formation occurs less frequently than thoserelated to open surgeries, the risk remains omnipresent as a result ofthe cumulative effect of the fibrin-forming inflammatory process.Factors that predispose the development of adhesions include: ischemia(poor blood supply), obesity, malnutrition, diabetes, or thedevascularization of the peritoneum caused by the surgery itself. Thedevelopment of adhesions generally occurs between the fifth and seventhpostoperative day, resulting in scar-like bands. These adhesive bandsmay surround the intestine and adhere them either together, or to theperitoneum of the interior abdominal wall. However, months to yearslater after the initial surgery, these constrictive bands may form athickened fibrous web, which, when fully compact, are capable ofinflicting severe pain or causing an intermittent-to-complete bowelobstruction. These two unfortunate scenarios will likely translate intohigher medical costs related to emergency surgical procedures, lengthyhospital admissions, and prolonged recovery periods.

The other complication related to minimally invasive procedures is theport-site wound hernia, also referred to as an incisional or ventralhernia. The port-site wound hernia is defined as the abnormal protrusionof abdominal viscera through the wound's fascial defect. This type ofhernia commonly develops in the first four years after the indexsurgery. At present, there is a problematic lack of long-term data onthe incidence and natural history of port-site hernia development.Significant contributing factors for port-site wound herniation relateto the size and location of the fascial defect.

Obese patients, with a body mass index (BMI) of thirty or greater, aremore susceptible to port-site wound herniation regardless of the fascialdefect's size. This may be attributed to the obese patient's enlargedpre-peritoneal space and/or tendency toward elevated intra-abdominalpressures. Extensive manipulation and stretching of the instrument portduring the MIS procedure (i.e. retrieval of specimens, multiplere-insertions, or aggressive use of laparoscopic instruments or devices)may enlarge the size of the fascial defect beyond the wound's initialdiameter thus rendering the fascial defect vulnerable to port-site woundherniation.

With regards to location, herniation occurs more frequently when thefascial defect is located in the midline of the abdomen, especially inthe upper midline area or at the umbilicus, possibly due to the absenceof supporting musculature in these areas. In contrast, port-site woundhernias occur less often when they are located below the umbilicus ormore laterally on the abdomen.

Another contributing factor for the development of a port-site woundhernia is known as the Chimney Effect. This describes a partial vacuumthat is created as the surgical cannula is withdrawn from the wound,much like a piston. As this negative pressure increases within thenarrow perimeter of the wound, it is capable of drawing abdominalviscera through the fascial defect and in the subcutaneous tissue or outof the body, thus creating the port-site wound hernia.

There are two technical risk factors for port-site wound hernia: thesurgical trocar design used for creating the wound, and/or the sutureused for closing the fascial defect. With regards to the former, thebladed trocar presents a greater risk for port-site wound herniadevelopment than non-bladed trocars. Port-site wound herniation may alsobe related to the repair of the fascial defect with suture, asexemplified by suture fractures, slipping of suture knots, excessivesuture tension, or sutures that absorb too rapidly. Suture closure ofthese wounds can be time consuming and difficult whether the suturingmethod is performed by the traditional approach (a needle attached to asuture and operated by a needle holder held in the operator's hand), orby a contemporary method using wound closure devices. The lattergenerally incorporates a needle or sharp tool with a suture affixed toone end in order to approximate and close the fascial defect.

Regardless of the method, the application involves the sametime-consuming and cumbersome approach for employing a needle (or sharptool) with a suture affixed to one end in order to approximate and closethe fascial defect within the narrow recesses of the port-site wound.Moreover, these suture techniques have the predictable risk of injuringthe underlying bowel, omentum, or other organs as the needle is sweptthrough the fascial tissues.

In obese patients, these suturing methods can be painstakinglydifficult, since the fascia is obscured from view by adipose tissue. Ifthe fascial defect is too deep and/or is located at a steep angledtrajectory in relation to its small skin incision, a blind attempt(e.g., with no direct vision) is the only option for closing the fascialdefect. This risky suturing effort generally fails to capture asufficient margin of the wound's edge.

With regards to the contemporary devices, they may share the same vexingdifficulties as the traditional method. However, a specific drawbackwith these devices relates to their requirement for a pneumoperitoneumand direct visualization during their surgical application. Thistime-consuming requirement proves problematic, since all of thesedevices are unable to close the port operating the telescopic lens.

These technical challenges can compromise the wound's integrity,resulting in complications such as poor wound healing, suture failure,and port-site wound herniation, all of which will inadvertently negatethe advantages of the MIS procedure. Ultimately, these complicationswill lead to increased pain and loss of productivity for the patient,while at the same time reducing efficiency with increased costs to thehealth care system in general.

SUMMARY OF THE DISCLOSURE

Since the advent and proliferation of minimally invasive surgeries therehas been a longstanding need for a rapid, safe and effective means ofclosing the strongest and most complete tissue layer of the port-sitewound, specifically the anterior fascia of the abdominal wall.Embodiments of the disclosure are directed to an apparatus and methodfor the optimal closure of minimally invasive port-site wounds that, incontrast to traditional and contemporary approaches for closing thefascial defect, include enhancements to prevent complications whilefacilitating wound healing.

By virtue of its unique one-piece design, the apparatus can function asits own insertion device, deployment tool, and highly sophisticatedtissue engineered implant. Regenerative medicine may play a role in thedevelopment of the wound plug's bio-chemical properties by exhibitingcharacteristics that, when exposed to living tissues of the body, maynot cause damage or adverse biological reactions (e.g., it may bebiocompatible); may physiologically degrade and may be absorbed during aspecific period of time (e.g., it may be bioabsorbable); and may becompletely eliminated by the body's natural processes with no residualside effects (e.g., it may be bioresorbable). These essentialcharacteristics may synergistically regenerate and heal the damagedtissues of the wound. The process can sustain the wound plug'sdurability and strength for the period of time deemed necessary for thewound plug to be absorbed by the body as the new tissues take its place.In this way, the apparatus can effectively, safely, and easily seal andclose the fascial defect of the port-site wound.

The apparatus can be inserted and deployed within any size, depth orangle of port-site wound. Due to its highly versatile design, theapparatus can accurately locate the anterior abdominal fasciasurrounding the fascial defect. The apparatus can ensure optimumapplication and deployment of its wound plug without necessitating theuse of any surgical cannula, pneumoperitoneum, or telescopic lens to aidin its insertion, delivery, or deployment.

The apparatus can secure closure of the fascial defect by deployment ofa unidirectional ratchet-rivet mechanism that engages the tissues of thefascial defect gently between two rivet heads. The apparatus can bedeployed above, below, and within the anterior fascial defect, causingthe defect to become gently sandwiched within the non-traumatic clampingforce of the apparatus's wound plug. This three-dimensional approach forclosing and sealing the defect echoes three basic tenets proposed inhernia mesh science. The first is the apparatus's suprafascial rivethead, which can secure the anterior fascial defect from above as anoverlay. The second is the apparatus's subfascial rivet head, which canaffix below the defect as an underlay. The third tenet can be achievedby the inlay position of the wound plug's shape memory column (stationedbetween the two rivet heads) that can fill and seal the void from withinthe fascial defect. The column can be compressible to fill any sizewound and to keep body tissue from entering the wound. Further, it canfill in any gaps to prevent the other elements of the wound plug fromshifting.

The tissues of the fascial defect may not be strictly fixed by theapparatus, which significantly reduces the detrimental effects of tissueischemia (poor blood supply) or necrosis (tissue death) within thewound. The wound plug can spread over a wide surface area, beyond thecircumference of the wound, to secure and promote tissue adherence andcellular growth. Another benefit of the wound plug's comprehensiveoverlay, underlay and inlay of the fascial defect and surroundingtissues is to prevent the plug from migrating or dislodging from itsdeployed position.

The straightforward and simple application of the apparatus may greatlyreduce operating room expenditures in time, efficiency and labor; reducerisk of future adhesions and herniation; facilitate healing andregeneration of the tissues; reduce pain in the patient; and promoteoptimal patient outcomes with a rapid recovery rate. The apparatus mayincorporate a wound plug that, by virtue of its varied chemical andbiological composition, may be capable of providing structural andmechanical support for the ingrowth and regrowth of native tissues byinteracting with the body's natural intra-cellular processes vital forwound healing.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the various described embodiments,reference should be made to the Detailed Description below, inconjunction with the following drawings in which like reference numeralsrefer to corresponding parts throughout the figures.

FIGS. 1A-1B illustrate the wound closure apparatus according toembodiments of the disclosure.

FIGS. 2A-2N illustrate the wound plug according to embodiments of thedisclosure.

FIGS. 3A-3B illustrate a post according to embodiments of thedisclosure.

FIG. 4 illustrates a rod according to embodiments of the disclosure.

FIGS. 5A-5C illustrate a shield according to embodiments of thedisclosure.

FIGS. 6A-6D illustrate the apparatus during stages of deployment of thewound plug according to embodiments of the disclosure.

FIG. 7 is a block diagram of a method for deploying a wound plugaccording to embodiments of the disclosure.

DETAILED DESCRIPTION

In the following description of examples, reference is made to theaccompanying drawings which form a part hereof, and in which it is shownby way of illustration specific examples that can be practiced. It is tobe understood that other examples can be used and structural changes canbe made without departing from the scope of the disclosed examples.

Since the advent and proliferation of minimally invasive surgeries therehas been a longstanding need for a rapid, safe and effective means ofclosing the strongest and most complete tissue layer of the port-sitewound, specifically the anterior fascia of the abdominal wall.Embodiments of the disclosure are directed to an apparatus and methodfor the optimal closure of minimally invasive port-site wounds that, incontrast to traditional and contemporary approaches for closing thefascial defect, include enhancements to prevent complications whilefacilitating wound healing.

By virtue of its unique one-piece design, the apparatus can function asits own insertion device, deployment tool, and highly sophisticatedtissue engineered implant. Regenerative medicine may play a role in thedevelopment of the wound plug's biochemical properties by exhibitingcharacteristics that, when exposed to living tissues of the body, maynot cause damage or adverse biological reactions (e.g., it may bebiocompatible); may physiologically degrade and may be absorbed during aspecific period of time (e.g., it may be bioabsorbable); and may becompletely eliminated by the body's natural processes with no residualside effects (e.g., it may be bioresorbable). These essentialcharacteristics may synergistically regenerate and heal the damagedtissues of the wound. The process can sustain the wound plug'sdurability and strength for the period of time deemed necessary for thewound plug to be absorbed by the body as the new tissues take its place.In this way, the apparatus can effectively, safely, and easily seal andclose the fascial defect of the port-site wound.

The apparatus can be inserted and deployed within any size, depth orangle of port-site wound. Due to its highly versatile design, theapparatus can accurately locate the anterior abdominal fasciasurrounding the fascial defect. The apparatus can ensure optimumapplication and deployment of its wound plug without necessitating theuse of any surgical cannula, pneumoperitoneum, or telescopic lens to aidin its insertion, delivery, or deployment.

The apparatus can secure closure of the fascial defect by deployment ofa unidirectional ratchet-rivet mechanism that engages the tissues of thefascial defect gently between two rivet heads. The apparatus can bedeployed above, below, and within the anterior fascial defect, causingthe defect to become gently sandwiched within the non-traumatic clampingforce of the apparatus's wound plug. This three-dimensional approach forclosing and sealing the defect echoes three basic tenets proposed inhernia mesh science. The first is the apparatus's suprafascial rivethead, which can secure the anterior fascial defect from above as anoverlay. The second is the apparatus's subfascial rivet head, which canaffix below the defect as an underlay. The third tenet can be achievedby the inlay position of the wound plug's shape memory column (stationedbetween the two rivet heads) that can fill and seal the void from withinthe fascial defect. The column can be compressible to fill any sizewound and to keep body tissue from entering the wound. Further, it canfill in any gaps to prevent the other elements of the wound plug fromshifting.

The tissues of the fascial defect may not be strictly fixed by theapparatus, which significantly reduces the detrimental effects of tissueischemia (poor blood supply) or necrosis (tissue death) within thewound. The wound plug can spread over a wide surface area, beyond thecircumference of the wound, to secure and promote tissue adherence andcellular growth. Another benefit of the wound plug's comprehensiveoverlay, underlay and inlay of the fascial defect and surroundingtissues is to prevent the plug from migrating or dislodging from itsdeployed position.

The straightforward and simple application of the apparatus may greatlyreduce operating room expenditures in time, efficiency and labor; reducerisk of future adhesions and herniation; facilitate healing andregeneration of the tissues; reduce pain in the patient; and promoteoptimal patient outcomes with a rapid recovery rate. The apparatus mayincorporate a wound plug that, by virtue of its varied chemical andbiological composition, may be capable of providing structural andmechanical support for the ingrowth and regrowth of native tissues byinteracting with the body's natural intra-cellular processes vital forwound healing.

Apparatus

FIGS. 1A-1B illustrate a wound closure apparatus 100 according toembodiments of the disclosure. The apparatus can be a self-containeddevice for delivery and deployment of a tissue engineered wound plug 200that can secure fascial closure of laparoscopic port-site wounds. Thewound plug 200 can include a subfascial rivet head 202, a suprafascialrivet head 204, and a compressible column 206, wherein the compressiblecolumn surrounds and is coupled to each of the subfascial rivet head andthe suprafascial rivet head.

The apparatus may include a post 300, a rod 400, and a shield 500 fordelivery and deployment of the wound plug 200. The post 300 can includethe subfascial rivet head 202 at a first end of the post and a handle322 at a second end of the post. The rod 400 can have a rod cavity 466through which the post 300 is positioned. A first end of the rod 400 canbe in contact with the suprafascial rivet head 204 of the wound plug200, and the rod can include a plate 426 at a second end of the rod. Theshield 500 can contain portions of the wound plug 200, the post 300, andthe rod 400 in a shield cavity 530.

Once in the wound, these components can deploy the wound plug 200 withthe subfascial rivet head 202 below the fascia 750 of the wound and thesuprafascial rivet head 204 above the fascia of the wound 748. As thisoccurs, the column 206 of the wound plug 200 can be stationed within theopening of the wound. Once the wound plug 200 is secured above, below,and within the fascial defect, the two components of the rivet heads 202and 204 may be interlocked within an inner channel 260 of the column206. As a result, the wound plug 200 may be implanted into the port-sitewound's fascial defect, while the post 300, the rod 400, and the shield500 may be removed from the wound and safely discarded.

The apparatus's design, consisting of its own deployment device andimplant, creates a mechanical symbiosis that precludes the need for anyother additional accessories (e.g., other tools or instruments), orconditions of the wound (e.g., pneumoperitoneum, telescopicvisualization, wound retraction, or increasing the length of the skinincision).

Wound Plug

FIGS. 1B and 2A-2N illustrate a wound plug 200 according to embodimentsof the disclosure. In some embodiments, the wound plug includes asubfascial rivet head 202, a suprafascial rivet head 204, and acompressible column 206. In some embodiments, the subfascial rivet head202 includes a subfascial extension 208 comprising a plurality of stays210, and the suprafascial rivet head 204 includes a suprafascialextension 212 including a plurality of stays 214. In some embodiments,the wound plug 200 further includes a subfascial biohybrid scaffold 216coupled to the subfascial extension 208 and a suprafascial biohybridscaffold 218 coupled to the suprafascial extension 212.

FIGS. 2A-2D illustrate subfascial and suprafascial rivet heads 202 and204 according embodiments of the disclosure. The rivet heads 202 and 204may be composed of natural polymers or copolymers like chitosan,gelatin, alginate, collagen and/or other wound healing promoters; aswell as synthetic polymers or copolymers such as Polyglycolide (PGA),Polylactide (PLA), Polydioxanone (PDO), Polycaprolactone (PCL), orsynthetic copolymers like L-lactide-co-glycolide (PLGA). Thepossibilities for such fabrication techniques may include but are notlimited to polymeric blends, dip coating, adhesive layering,copolymerization, grafting, homogeneous mixtures, and/or electrospinningfor creating a biosynthetic composite material.

This skeletal architecture can be manufactured from a polymericcomposite for superior tissue engineering. A synthetic polymer orcopolymer may be desirable because it demonstrates mechanical andphysiochemical characteristics similar to those of the biological tissueit will temporarily replace. Additionally, synthetics can be tailored tocontrol their microstructure and degradation rate. In contrast, however,natural polymers can have bioactivity-possessing growth factors andpertinent signals that may facilitate cellular adhesion, growth, andproliferation. Consequently, the strength of the former, and thebioactivity of the latter may mutually provide intrinsic benefits whilediminishing each other's deficiencies.

The semi-rigid polymer composite of this skeletal architecture can bedesigned with microscopic perforations, which provide a gradient throughwhich the native tissue cells may proliferate. As the device degradeswithin the body these perforations may be critical for tissue adherenceand optimal cellular response and healing. Moreover, a natural polymermay be adhered as a layer upon the synthetic polymer construct.

The subfascial rivet head 202 may be a part of the post 300 at a firstend of the post, separated from the rest of the post by a breakawaypoint 320. The post 300 can be used to position the subfascial rivethead 202 below the fascia 750 into the pre-peritoneal space, and thepost can be broken at the breakaway point 320 to separate the subfascialrivet head 202 from the rest of the post after the wound plug 200 isdeployed in its entirety.

In some embodiments, the subfascial rivet head 202 may comprise anengaging ratchet configured to engage with a hollow receiving pawl ofthe suprafascial rivet head 204. For example, the engaging ratchet mayinclude a number of flanges 256 configured along its exterior thatcorrespond to a number of reciprocal annular grooves 258 within theinterior of the receiving pawl. Once the rivet heads 202 and 204 aredeployed, the subfascial and suprafascial portions of the wound plug 200become interlocked by deployment of the unidirectional mechanism.

In some embodiments, the suprafascial rivet head 204 may comprise ahollow receiving pawl configured to engage with an engaging ratchet ofthe subfascial rivet head 202. For example, the receiving pawl mayinclude a number of reciprocal annular grooves 258 configured within itsinterior that correspond to a number of flanges 256 on the exterior ofthe engaging ratchet. Further, the suprafascial rivet head 204 may beconfigured with a channel to allow the post 300 to pass through itshollow core.

In some embodiments, engagement of the subfascial and the suprafascialrivet heads 202 and 204 may be confirmed by three audible clickssynchronized with three tactile sensations. These effects confirm thatthe reciprocal annular grooves 258 of the receiving pawl havesuccessfully interlocked with the flanges 256 of the engaging ratchet.

In some embodiments, extensions 208 and 212 surround the outerperimeters of each rivet head 202 and 204. For example, FIGS. 2E-2Fillustrate each extension 208 and 212 including a plurality of stays 210and 214. In some examples, the number of stays on each rivet head can bechosen relative to the size of each rivet head extension 208 and 212, aswell as to the weight and size of their associated biohybrid scaffold216 and 218. The cross sectional profile of each stay may be tapered onone side 262 and non-tapered (e.g., flat) on the opposing side 264. Thisprofile can be consistent throughout the length of each stay,terminating into a blunt-point end.

The stays 210 and 214 may be fabricated using shape memory properties,allowing for two different configurations during the implant's surgicalapplication. Prior to deployment, the stays may project at 90° anglesfrom the outer perimeter of each rivet head, offset relative to eachother at a 45° angle of arc. In this second configuration, the stays maybe superiorly and inferiorly convergent as they enclose an outer wall ofthe column 206 in an alternating fashion. Further, each stay may includetwo distinct surfaces 262 and 264. Within the apparatus 100, a firstnon-tapered surface 264 may be adjacent to the wall of the column 206,whereas a second tapered surface 262 may encircle an outer perimeter ofthe column 206 exteriorly.

Once the rivet heads 202 and 204 are deployed, however, the shape memoryproperties of the stays 210 and 214 can be immediately affected by thebody's temperature and/or pH relative to a pre-determined time intervalalso inherent in their chemical properties. These physical andbiological properties can cause each stay to automatically deploy itscorresponding biohybrid scaffold (e.g., biohybrid scaffolds 216 and/or218) into a full radial expansion above and below the fascial defect,thus orienting the stays' non-tapered surfaces 264 toward the abdominalfascia, while their tapered surfaces 262 are adjacent to the nativetissues surrounding the port site wound (e.g., native tissues 768 inFIGS. 6C and 6D).

Although FIG. 2E illustrates just the subfascial extension 208 includingthe plurality of stays 210, in some embodiments, the subfascialextension 208, the plurality of stays 210, the subfascial rivet head202, and the post 300 are all formed of a single piece. Further,although FIG. 2E illustrates just the suprafascial extension 212including the plurality of stays 214, in some embodiments, thesuprafascial extension 212, the plurality of stays 214, and thesuprafascial rivet head 204 are all formed of a single piece.

In some embodiments, the rivet heads 202 and 204 may include a discshape as illustrated in the figures. In some embodiments, the rivetheads may alternatively include other shapes, such as rectangular, oval,hexagonal, octagonal, star, square, etc.

In some embodiments, the rivet heads 202 and 204 may be manufacturedfrom the same shape memory blend of natural and synthetic polymers (orcopolymers) as the extensions 208 and 212. In this way, the rivet headscan change to a smaller or more compact profile, such as a cone or ball.

In some embodiments, the stays 210 and 214 may be profiled to be taperedor non-tapered, thick or thin, wide or narrow, etc. In some embodiments,the stays may be profiled in such a way that their central convergenceforms the receiving pawl and engaging ratchet. In this embodiment, thestays may be configured in linear geometric shapes (i.e., spokes on abicycle wheel, or a lattice-like network), or as a mosaic ofcrisscrossing curves (i.e., lace-like or snowflake designs) forestablishing the skeletal framework of the rivet heads 202 and 204, aswell as the rivet head extensions 208 and 212.

Although embodiments of the disclosure are described in terms of rivetheads comprising a receiving pawl and an engaging ratchet, embodimentsare not so limited. Other embodiments are contemplated for attaching thesuprafascial and subfascial portions of the wound plug 200, such assuperior and inferior clasps, mechanical fasteners, crimp engagements,mechanical latches, suture tie(s) with a type of slip knot(s), post orbead-like snaps, a tapering pin that engages within a narrowing hole,hook and eye attachments, a type of buckling apparatus, or even achemical tissue adhesive disseminating from the column 206.

FIGS. 2G-2J illustrate biohybrid scaffolds 216 and 218 according toembodiments of the disclosure. In some embodiments, the scaffolds 216and 218 may comprise a collagen rich acellular non-crosslinked tissuesheet that is replete with vital components for wound healing, such aslaminin, biometric proteins, carbohydrates, etc. When thesemulti-layered tissue sheets are applied to a wound site, a synergybetween its scaffold and the native tissues can develop, causingspecialized living cells to proliferate and regenerate new tissue intothe wound site.

In some embodiments, the biohybrid scaffolds 216 and 218 include twodistinct surfaces. A first surface 252, the lamina propria layer, may beconducive for tissue regeneration and healing. In contrast, the secondsurface 254, the epithelial basement membrane, may be beneficial as acollagen rich tissue scaffold. The scaffolds may be deployed such thatthe first surface 252 is in contact with the abdominal fascia around thefascial defect 748 and 750, while the second surface 254 is in contactwith surrounding native tissues of the wound (e.g., native tissues 768in FIGS. 6C and 6D).

In some embodiments, the biohybrid scaffolds 216 and 218 may cover andembed only the flatter, larger surfaces of the rivet heads 202 and 204and both sides of each of the stays 210 and 214 with the exception ofthe stays' distal blunt ends. The scaffolds 216 and 218 may includecentralized openings to allow portions of the rivet heads 202 and 204and the vertical axis of the post 300 to pass through the centers of thescaffolds.

In some embodiments, an electrospun layer may be applied between thetissue surfaces of each biohybrid scaffold 216 and 218 directlycontacting the shape memory components of the stays 210 and 214. Thismay further promote cohesiveness between the two layers for strength andmanageability.

Prior to deployment biohybrid scaffolds 216 and 218 can conform to thesame constricted configuration presented by the embedded stays 210 and214. In this deformed profile, the lamina propria layer 252 can beadjacent to the wall of the column 206, while the epithelial basementmembrane 254 can encircle the column exteriorly. In this pre-deploymentprofile, the scaffold tissue sheets may appear as multiple verticalpleats, in the likeness of a pleated paper coffee filter, althoughpleats may be more rounded or larger in nature.

Once the rivet heads 202 and 204 are deployed, the bio-reactivity of thesurrounding stays 210 and 214 can simultaneously spread itscorresponding biohybrid scaffold 216 and 218 into full radial expansion.As a result, the lamina propria layer 252 that encases the inner(fascial) surfaces of the rivet heads and stays (e.g., the non-taperedsurfaces 264) may be juxtaposed to one another as they cover thesubfascial and suprafascial surfaces 750 and 748 surrounding the wound744. Further, the epithelial basement membrane 254 covering the exteriorsides of the rivet heads and the tapered surfaces 262 of the stays canbuttress the surrounding native tissues (e.g., native tissues 768 inFIGS. 6C and 6D). Consequently, following deployment each rivet head'souter diameter may be large enough to thoroughly cover both sides of thedefect.

In some embodiments, the scaffolds may be produced with other types ofbiological or synthetic (absorbable or nonabsorbable) scaffoldingmaterials.

In some embodiments, the skeletal framework of the rivet heads and thestays may not be included, and instead the shape memory biohybridscaffolds of each rivet head may be resilient enough to deform into apre-deployment configuration without the necessity of any supportiveskeletal framework.

In the absence of the skeletal framework, it may be beneficial for atissue adhesive to be dispersed from the column 206 to cause the twobiohybrid scaffolds to adhere locally to the wound. If a tissue adhesiveis used for securing the wound plug to the wound, there may be no needfor a mechanical fixation apparatus such as an engaging ratchet or areceiving pawl. As a result, this alternative suggests only a simpleopen-ended central opening within the suprafascial rivet head 204.Likewise, the post 300 may be a plain shaft (without an engaging ratchetor a breakaway point 320). The distal end of the post may need to betenuously anchored to the electrospun network within the two layers 252and 254 of the subfascial biohybrid scaffold 216 covering the subfascialrivet head 202. After deployment, and the local tissue adhesive from thecolumn 206 is dispersed, the terminal end of the post may be twisted,torqued, pulled, or snapped from its temporary electrospun attachmentswithin the subfascial biohybrid scaffold of the subfascial rivet head.

In some embodiments, the biohybrid scaffold 216 and 218 may be uniform,and may have wide or narrow shapes that may include oval, rectangular,star-like or flower-petal projections, etc. In some embodiments, thesubfascial and suprafascial biohybrid scaffolds may be profiled in twoentirely different geometric shapes and widths. Further, each scaffoldmay be fabricated from identical biological or chemical properties tothat of other elements of the wound plug 200.

FIGS. 2K-2N illustrate a compressible column 206 according toembodiments of the disclosure. The column 206 may be a highly porousshape-memory structure, in the form of a sponge or foam, which providesa large surface area to promote cellular ingrowth, uniform cellulardistribution, and neovascularization. The column may be centered betweenthe two rivet heads 202 and 204. Prior to deployment, the receiving pawland the engaging ratchet may be recessed within an inner channel 260 ofthe column. In some embodiments, the column may further include anelectrospun network between the terminal borders of the column and thefascial surfaces 252 of the biohybrid scaffold 216 and 218 to achieve anintegrated fusion between these structures, thus uniting them togetheras a single unit. As a result, the column's inferior section may bedeployed in unison with the subfascial rivet head 202, while thesuperior portion of the column may be deployed with the suprafascialrivet head 204. After deployment, the column's initial tube-like profilemay be positioned within the border of the wound.

The wall of the column 206 may be constructed with multiple compactcircumferential pleats, such that the column compresses in anaccordion-like fashion as the subfascial and suprafascial portions ofthe wound plug become interlocked. Accordingly, the length of the columncompresses while maintaining its outer diameter so as to not interferewith the interlocking of the rivet heads.

In some embodiments, once the pleats are mechanically compressed, thebody's temperature and/or pH can affect shape memory properties of thecolumn 206, causing the column to automatically expand and pervade theinterior of the wound in a washer-like profile with an outer diameterthat does not fill the central defect. This smaller diameter of thecolumn's washer-like profile can allow for the porous network to absorbblood and body fluids, increasing in size to swell and pervade the woundlike a seal. The final configuration of the column, therefore, may fillthe central defect like a low-pressure seal or plug without exertingpressure on the bordering tissues of the wound. As a result of thisseal, the inner channel 260 of the column may become completelyobliterated, thus resulting in an adherence between the column and theengaged components of the rivet heads 202 and 204. The benefit of thisadherence is that dead space and vacuums are averted within the interiorof the wound plug 200, thereby encouraging tissue regeneration.

In some embodiments, the size, distribution, volume, shape, androughness of pores within the column 206 may have a powerful influenceon cellular penetration and growth. Further, the pores may beinterconnected in order to facilitate the essential transfer of oxygen,nutrients, and other physiochemical elements and biological exchanges toand from the living cells.

In some embodiments, the porous structure of the column 206 may besaturated with either a bioactive cellular matrix powder or abiocompatible hydrogel. Saturating the column with one or more of thesematerials can promote a synergistic interplay between it and thesurrounding native tissues of the port-site wound. Additionally, thecolumn's porous construction can incorporate pharmaceutical enhancementsinto its design, such as tissue adhesives, stem cell recruitmentadjuncts, regenerative biochemical factors, insulin growth factor,anesthetic or antibiotic time-released drugs, etc.

In some embodiments, the inner channel 260 of the column 206 surroundingthe post 300 and portions of the rivet heads 202 and 204 may be filledwith a tissue-healing hydrogel or liquefied state of the same. Followingdeployment, the locally applied tissue adhesive may be dispersed fromthe column to function as a chemical securing mechanism for sealing thewound plug to the wound. In some embodiments, the column 206 itself maybe made of the hydrogel with an outer wall made of denser gelatinousmaterial (or skin) which encases the more viscous and/or liquefied form.

In some embodiments, the column 206 may include a finely shredded orspider web-like form of the bioactive acellular tissue matrix and/orliquefied form of the same. In some embodiments, the column may befabricated from any number of materials including a sponge, foam,hydrogel, acellular pig bladder xenograft, any other type of xenografts,synthetic-absorbable scaffolding material, or any combination of theseoptions. In some embodiments, the column may occur as a hollow chamber(i.e., a small bladder) formed by either a xenograft or other type oftissue engineered material that may contain pharmaceutical and bioactivesubstances, hydrogel, and/or the possibility of a tissue adhesive withinits interior.

In some embodiments, the column 206 may be formed by stacking multiplecentrally-perforated washers, one on top of the other, around the post300 and the mechanical securing mechanisms of the rivet heads 202 and204.

In some embodiments, the pleats of the column 206 may be arranged invertical columns, or curving these vertical columns into a spiraling,candy cane-like design. By arranging the folds or pleats in theseconfigurations, the column may compress like a collapsed spring.Moreover, it may be advantageous to cut these vertical or horizontallines rather than utilizing pleats and/or folds within the wall of thecolumn. Additionally, a combination of cuts and/or pleats or folds maycontribute to a more successful compression for the column duringdeployment.

Delivery and Deployment Apparatus

The post 300, the rod 400, and the shield 500 form an apparatus 100 fordelivery and deployment of the wound plug 200. These three componentsmay reside at different radial levels in the apparatus. The post 300 maybe located in the core of the apparatus and may be the longest of thethree components, with its handle 322 rising higher than the other twocomponents. The rod 400 surrounds portions of the post 300 and includesa plate 426 at one end (e.g., approximately midway between the handle322 of the post 300 and grips 538 of the shield 500). The shield 500surrounds portions of the rod 400 and the post 300 in its shield cavity530. The shield includes an implant chamber 532 that contains portionsof the wound plug 200 before deployment. Each of the post, the rod, andthe shield may include an alignment pin hole through which an alignmentpin 600 may be placed to align the various components with respect toeach other. The alignment pin 600 may be removed prior to deployment, asdescribed below.

In some embodiments, each of the post 300, the rod 400, and the shield500 may be made of synthetic polymers without the essential blends ofpolymer composites comprising the wound plug 200. As a result, theoverall rigid construction of these elements (e.g., the elements thatwill not be implanted within the body) may be fabricated fromnon-critical, bio-safe materials. Once the post, the rod, and the shieldare separated from the wound plug and removed from the wound, theirbyproducts may be safely discarded as environmentally friendly,non-toxic wastes.

FIGS. 3A-3B illustrate a post 300 according to embodiments of thedisclosure. The post may be a vertical and most internal axis by whichall the components of the apparatus 100 may be collectively aligned andintegrated for deployment. In this unique position, the post maytraverse proximally throughout a series of internal conduits of thecolumn 206 (e.g., the inner channel 260 of the column), the suprafascialrivet head 204, the rod 400 (e.g., the inner channel 466 of the rod),and the shield 500 (e.g., the shield cavity 530). The alignment of thesecannulated components can create a common passageway through whichportions of the post 300 can move.

The post 300 may be an injected molded structure comprised of severaldiverse profiles along its vertical construct, including a subfascialrivet head 202 (e.g., the engaging ratchet) at a first end, and a handle322 at a second end. The post may further include a breakaway point 320between the subfascial rivet head and the handle. The breakaway pointdistinguishes the portion of the post included in the wound plug (i.e.,the subfascial rivet head) from the rest of the post. In someembodiments, the breakaway point 320 may be configured to providevertical stability and strength, thereby resisting compression orelongation during insertion and deployment. However, following theapplication of minimal twisting torque to the handle 322, the post 300can break at the breakaway point.

In some embodiments, the post 300 retains a cruciate profile until ittransitions into the inferior flanges 256 and distal base of theengaging ratchet. Although the subfascial rivet head 202 is illustratedas having three flanges 256, embodiments are not so limited and can haveany number of flanges. The handle 322 may be knurled to facilitategripping and cylindrical to prevent its descent into the rod 400. Insome embodiments, the post 300 further includes an alignment pin hole324.

In some embodiments, the handle 322 may be profiled in different shapeswhich include, but are not limited to, a round, flat plate or disc,T-handle, thumb plate, ball, bulb, laterally contoured projections,finger-ring holes, diamond, ribbed finger grip, a rod-like handle, etc.In some embodiments, the shaft of the post 300 may be formed in othernon-cruciate shapes, such as geometric shapes like a triangle ordiamond, or a simple round or oval profile. Moreover, one or more of thefour cruciate crossarms may be added to or removed from the cruciateprofile, thus allowing for a variety of shapes which include, but arenot limited to, one crossarm projection, two crossarms similar to adumb-bell shape, three crossarms like a rounded three-leaf clover or apointed triangular shape, a diamond shape, or multiple rounded orpointed projections as seen in various flower or star-like profiles.

In some embodiments, the breakaway point 320 may be designed to severeither by a snap release, by pulling and/or twisting, or by otherphysical means, instead of the application of torque discussed above.Additionally, since many of the apparatus's components respond to thebody's pH and/or temperature, the breakaway point's chemical propertiesmay be engineered to release within a specific period of time, shortlyafter deploying the wound plug 200 within the wound.

FIG. 4 illustrates a rod 400 according to embodiments of the disclosure.The rod 400 can include a plate 426 at a second end of the rod, and afirst end of the rod can be in contact with the suprafascial rivet head204 (e.g., the receiving pawl). Prior to deployment, the plate 426 maybe positioned midway between the handle 322 of the post 300 and thegrips 538 of the shield 500. The rod may further include an alignmentpin hole 428. An inner channel 466 of the rod can match a cruciateprofile of the post 300, allowing for the vertical movement of the postand the rod without twisting during deployment of each associated rivethead (subfascial rivet head 202 deployed by the post 300, andsuprafascial rivet head 204 deployed by the rod 400). Further, thecruciate profile can facilitate fixation of the post 300 above itsbreakaway point 320, permitting the application of torque to sever thepost at the breakaway point.

In some embodiments, the combination of the plate 426 of the rod 400 andthe grips 538 of the shield 500 can allow for a syringe-like hold todeploy the suprafascial rivet head 204 and the superior section of thecolumn 206, as described below. In some embodiments, the inner channel466 of the rod 400 has a non-cruciate shape to match a correspondingnon-cruciate shape of the post 300. In some embodiments, thesuprafascial rivet head 204 can be a part of the rod 400, separated fromthe plate 426 by a breakaway point that functions similarly to thebreakaway point 320 of the post 300. The breakaway point of the rod canalign with the breakaway point of the post after deployment such that asingle twisting motion can sever both.

Although the figures illustrate a single shape for the plate 426,variations in shapes, thicknesses, sizes, etc. are contemplated by thisdisclosure.

FIGS. 5A-5C illustrate a shield 500 according to embodiments of thedisclosure. The shield 500 can include a shield cavity 530 and animplant chamber 532 that houses portions of the wound plug 200 prior todeployment. In some embodiments, the shield further includes grips 538to allow a user to hold the device like a syringe with a comfortablegrip for the deployment of the suprafascial rivet head 204 and thecolumn 206. The implant chamber 532 may be profiled in an invertedcup-like configuration. A rim of the implant chamber may be wider thanthe wound in the fascia, such that the shield 500 can rest on the fasciawithout entering the wound 744, and so that the contact between thefascia and the rim provides physical feedback to the user indicatingthat the wound plug is correctly positioned with respect to the depth ofthe fascia beneath the skin, allowing for use of the apparatus withoutinternal or external direct vision of the wound 744. Further, the rim ofthe implant chamber may include an insertion lip 534 to facilitate easyinsertion of the apparatus beneath a narrow skin incision.

In some embodiments, the shield 500 may further include an alignment pinhole 536. The linear arrangement of the three alignment pin holes in thepost 300, the rod 400, and the shield 500 can create a common openingfor insertion of an alignment pin 600 to keep the components in placeuntil ready for deployment, as illustrated in FIG. 5C. The alignment pinmay be removed once the rim of the implant chamber 532 is centered overthe wound in the fascia.

In some embodiments, the insertion lip 534 of the implant chamber 532may project in shapes including a quarter or half circle, a quarter orhalf oval, a more pointed design, an encircling band or brim, a ring, ora ridge. One or more additional insertion lips may also be included onthe rim of the implant chamber 532.

In some embodiments, a CO₂ sensor or pressure gauge may be devised alongthe rim and/or lip of the implant chamber 532, which can register avisual cue in a window constructed within the wall of the shield 500.

In some embodiments, concentric grooves appearing as screw-like threadsor spiral-like grooves may be profiled to the exterior wall of theshield 500. The purpose of these grooves may be to promote an easierinsertion of the device within the subcutaneous tunnel of the wound.However, it may be determined that vertically aligned grooves, incontrast to the horizontal grooves, like the screw or spiral-likeprofiles, may effect easier insertion of the apparatus into the wound.

In some embodiments, some or all of the shield 500 may be profiled innumerous shapes, sizes, thicknesses, etc. For example, the grips 538 maybe profiled in any geometric shape for designing the laterally orientedprojections or rings, and any number of grips are contemplated.

Method of Deployment

FIGS. 6A-6D illustrate the apparatus 100 during stages of deployment ofthe wound plug 200, and FIG. 7 is a block diagram of a method fordeploying a wound plug according to embodiments of the disclosure.

The shield 500 may be inserted (10) into a skin opening 742 in the skin740. The shield's implant chamber 532 may be slightly larger than theskin opening 742, so holding the apparatus at a 45° angle may allow theapparatus to slip easily beneath the skin incision without extension ofthe wound or the need for skin retraction.

The shield may be positioned (20) such that the rim of the implantchamber 532 is in contact with a suprafascial surface 748 of fascia 746surrounding a wound 744 in the fascia, as illustrated in FIGS. 6A-6B. Insome embodiments, the rim of the implant chamber may be wider than thewound in the fascia, such that the shield can rest on the fascia 746without entering the wound 744, and allowing for use of the apparatuswithout internal or external direct vision of the wound in the fascia.Further, the contact between the fascia and the rim may provide physicalfeedback to the user that the wound plug is correctly positioned withrespect to the depth of the fascia 746 beneath the skin 740.

In some embodiments, the alignment pin 600 may be removed from thealignment pin holes 324, 428, and 536 of the post 300, the rod 400, andthe shield 500, respectively.

The post 300 may be moved (30) towards the wound 744 (e.g., by grippingand moving the handle 322 of the post) such that a subfascial extension208 coupled to the subfascial rivet head 202 (e.g., engaging ratchet) atthe first end of the post passes through the wound. The subfascial rivethead 202, the subfascial biohybrid scaffold 216, and an inferior portionof the column 206 may thereby pass into the native tissues 768 of thepre-peritoneal space.

After the subfascial extension 208 passes through the wound 744, thepost 300 may be moved (40) such that the subfascial extension is incontact with a subfascial surface 750 around the wound 744 (e.g., bygripping and pulling the handle 322 of the post until resistance is feltwhen the subfascial extension comes into contact with the subfascialsurface). The subfascial biohybrid scaffold 216 and correspondingsubfascial plurality of stays 210 of the subfascial extension may befully radially expanded at this point below the fascial defect withinthe pre-peritoneal space. Further, the inferior portion of the column206 containing a portion of the subfascial rivet head 202 may positionedwithin the wound.

The rod 400 may be moved (50) toward the wound 744 (e.g., by holding thehandle 322 of the post 300 in a stationary position with one hand, andwith the opposite hand pushing together in a syringe-like manner thegrips 538 of the shield 500 and the plate 426 of the rod). As a resultof this motion, the receiving pawl 204 may be pushed by the rod towardsthe engaging ratchet 202, the engaging ratchet may interlock within thereceiving pawl, the compressible column 206 may be compressed within thewound, and a suprafascial extension 212 (e.g., including a plurality ofstays 214) coupled to the receiving pawl may be in contact with asuprafascial surface 748 around the wound 744, as illustrated in FIG.6C. The interlocking of the receiving pawl and the engaging ratchetwithin the inner channel 260 of the column 206 may cause the mechanicalcompression of the column within the wound 744, as illustrated in FIG.6D. Further, the suprafascial biohybrid scaffold 218 and correspondingsuprafascial plurality of stays 214 of the suprafascial extension may befully radially expanded at this point. As a further result of thismotion, portions of the wound plug 200 may be driven out of the implantchamber 532, and the implant chamber may be lifted off the suprafascialsurface 748 to allow for unrestricted clearance of the suprafascialrivet head 204 and the column 206 into the wound 744. Further, threeconsecutive clicks may be heard and felt by a user to indicate that thewound plug is fully deployed.

In some embodiments, the post 300 may be twisted to break the post atthe breakaway point 320 such that the engaging ratchet is separated fromthe post, as illustrated in FIG. 6D. In some embodiments, both an outerprofile of the post and an inner profile of the rod cavity have acruciate shape, such that post is prevented from rotating within the rodcavity (e.g., to facilitate the application of torque to a breakawaypoint of the post when the rod is twisted).

In some embodiments, any or all components of the apparatus may beassembled within any disposable or non-disposable surgical gun orapplier, and these may be designed with automatic reloads of the woundplug, either within the apparatus or applied separately to it, forsequential and repetitive deployment.

In some embodiments, the wound plug 200 may afford stabilization and/orhealing of any type of penetrating wound caused by traumaticallyimpaling the fascia anywhere on the body. The wound plug mayappropriately address various types of hernias within the abdominalwall. The wound plug's postoperative antimicrobial benefits may befeasible for the primary closure of fistulated tracks or other types ofreoccurring infected wounds. The wound plug's antimicrobial andanesthetic advantages, as well as its ability for completely healingthese chronic wounds, may eliminate lengthy secondary or tertiaryhealing attempts, which often succumb to re-infection and reoccurrence.By application of the apparatus 100, the wound plug 200 may beconsidered possible for closing the abdominal fascial defect of a stoma(i.e., colostomy) following surgical re-anastomosis of the bowel. Thewound plug may close any fascial defect following the removal of anylarge drainage tube, surgical tube, or port that is at high risk forherniation or poor wound healing, in general.

In some embodiments, the wound plug 200 may be made to address anylength or shape of fascial incision anywhere on the body, with orwithout the incorporation of sutures for reinforcement. For example, thewound plug may be in a more rectangular and linear profile, thusallowing for its repetitive and sequential application along the fascialincision line. Fascial incisions may include, but are not limited to,any region of the abdomen (i.e., midline or transverse laparotomyincisions), any location on the extremities (i.e., incisions forrepairing fractured bones or joint replacement arthroplasties),posterior or flank regions of the torso (i.e., spinal or kidneyincisions), or fascial planes covering the anterior, lateral, orposterior areas of the chest wall (i.e., video assisted openthoracostomy port-site wounds or thoracostomy incisions).

In some embodiments, the apparatus 100 may be designed to incorporate afiber optic cable with an optical lens to allow for direct visualizationof the subcutaneous tunnel and anterior abdominal fascia during itsinsertion and deployment within the wound. Although embodiments of thedisclosure are described without requirement of a pneumoperitoneum,intra-abdominal telescopic lens, or any other instrumentation, theapparatus may be used in conjunction with such devices.

In some embodiments, the apparatus 100 may further include one or moreelements to enhance light (or visual), auditory, or palpatory sensationswhen the rim of the shield 500 reaches the wound in the fascia 746and/or as confirmation of accurate completion of other various stepsduring deployment. For example, a rim or lip 534 of the shield 500 mayfurther include a touch-sensitive surface (mechanical, capacitive,and/or resistive, among other possibilities) to confirm that the rim hasreached the wound in the fascia. Further, an audible sound may confirmthe subfascial rivet head's placement below the fascia, and a lightsensor may confirm engagement of the suprafascial and subfascial rivetheads (or any combination of sensor feedback).

In some embodiments, the apparatus 100 may further include a button-typeretaining pin (either spring or manually designed) which, by virtue ofits configuration, could function to lock and unlock the post 300. Oncethis retaining pin is pushed in to become flush with an external wall ofthe shield 500, a grooved configuration would release only the post 300,allowing its downward movement for deploying the subfascial rivet head202.

In this embodiment, the alignment pin 600 can interlock the actuator rod400 and shield 500 together prior to their deployment. After a userpushes the button of the retaining pin forward (toward the shield 500),the post 300 is released and may slide down as previously described.When the user pulls the post 300 upward in order to palpate thesubfascial tissue 750, the retaining pin of the post may be pulled backtoward the operator, out of its hole, until it engages the post in itslocked configuration. Following the aforementioned activity of thepost's retaining pin, the alignment pin 600 can be pulled out to releasethe rod 400 and the shield 500 for their deployment of the suprafascialrivet head 204. Naturally, with regards to this alternative, theprofiles of the rod 400 and shield 500 would need to incorporate somesort of detent/horizontal slots or grooves to allow for their deploymentactivities over and alongside the presence of this stationary retainingpin. Such a configuration may allow for a more controlled and sequentialrelease of the elements incorporated within the apparatus 100, freeingthe user from needing to hold the post 300 stationary during theactivation of the rod 400 and shield 500.

Although the disclosed examples have been fully described with referenceto the accompanying drawings, it is to be noted that various changes andmodifications will become apparent to those skilled in the art. Suchchanges and modifications are to be understood as being included withinthe scope of the disclosed examples as defined by the appended claims.

What is claimed is:
 1. A method for deploying a wound plug, the methodcomprising: inserting a shield into a skin opening, wherein the shieldcontains portions of a wound plug, a post, and a rod in a cavity of theshield, the wound plug is positioned in an implant chamber of the cavityof the shield that is wider than an adjacent portion of the cavity ofthe shield, and the wound plug includes an engaging ratchet, a receivingpawl, and a compressible column; positioning the shield such that a rimof the implant chamber is in contact with a suprafascial surface offascia surrounding a wound in the fascia; moving the post towards thewound such that a subfascial extension coupled to the engaging ratchetat a first end of the post passes through the wound; after thesubfascial extension passes through the wound, moving the post such thatthe subfascial extension is in contact with a subfascial surface aroundthe wound; and moving the rod towards the wound such that: the receivingpawl is pushed by the rod towards the engaging ratchet, the engagingratchet engages within the receiving pawl, the compressible column iscompressed within the wound, and a suprafascial extension coupled to thereceiving pawl is in contact with a suprafascial surface around thewound.
 2. The method of claim 1, wherein both an outer profile of thepost and an inner profile of a cavity of the rod have a cruciate shape,such that post is prevented from rotating within the cavity of the rod.3. The method of claim 1, wherein the post further includes a breakawaypoint between the engaging ratchet at the first end of the post and ahandle at a second end of the post, the method further comprising:pulling or twisting the post to break the post at the breakaway pointsuch that the engaging ratchet is separated from the post.
 4. The methodof claim 1, wherein each of the post, the rod, and the shield includesan alignment pin hole, the method further comprising: prior to movingthe post towards the wound such that the subfascial extension passesthrough the wound, removing the alignment pin from the alignment pinholes.
 5. The method of claim 4, wherein removing the alignment pin fromthe alignment pin holes releases the rod and the shield.
 6. The methodof claim 1, wherein the rim of the implant chambers includes aninsertion lip, the method further comprising: locating an anteriorfasicia proximate to the wound; and preventing the insertion lip fromcontacting the wound.
 7. The method of claim 1, wherein portions of eachof the subfascial extension and the suprafascial extension have a firstconfiguration in the cavity of the shield and change to a secondconfiguration in response to an increase in temperature or a change inpH.
 8. The method of claim 7, wherein each of the subfascial extensionand the suprafascial extension includes a plurality of stays, whereinchanging to a second configuration includes: radially extending theplurality of stays around an axis of the post; and radially offsettingthe plurality of stays of the subfascial extension relative to theplurality of stays of the suprafascial extension.
 9. The method of claim8, wherein an electrospun layer is included between the subfascial andsuprafascial extensions, the method further comprises: connecting thesubfascial and suprafacial extensions to the plurality of stays usingthe electrospun layer.
 10. The method of claim 1, wherein the wound plugfurther comprises a subfascial biohybrid scaffold coupled to thesubfascial extension, a suprafascial biohybrid scaffold coupled to thesuprafascial extension, and an electrospun layer, the method furthercomprising: contacting the subfascial biohybrid scaffold and thesuprafascial biohybrid scaffold to the respective plurality of staysusing the electrospun layer.
 11. The method of claim 1, wherein an innerprofile of the cavity of the rod has a cruciate shape, and the postfurther includes a breakaway point between the engaging ratchet at thefirst end of the post and a handle at a second end of the post, themethod further comprising: creating a counter-resistance between thepost and the breakaway point.
 12. The method of claim 1, wherein thecompressible column includes a plurality of pores or a plurality ofpleats, the method further comprising: absorbing one or more fluidsusing the plurality of pores and pleats.
 13. The method of claim 1,wherein the compressible column includes a plurality of pores or aplurality of pleats, the method further comprising: dispersing amaterial from the compressible column.
 14. The method of claim 1,further comprising: creating audible clicks and tactile sensations whenannular grooves of the receiving prawl interlock with flanges of theengaging ratchet.
 15. A method for deploying a wound plug, the methodcomprising: inserting a shield into a skin opening, wherein the shieldcontains portions of a wound plug, a post, and a rod in a cavity of theshield, the wound plug is positioned in an implant chamber of the cavityof the shield that is wider than an adjacent portion of the cavity ofthe shield, and the wound plug includes a subfascial rivet head, asuprafascial rivet head, and a compressible column; positioning theshield such that a rim of the implant chamber is in contact with asuprafascial surface of fascia surrounding a wound in the fascia; movingthe post towards the wound such that a subfascial extension coupled tothe subfascial rivet head at a first end of the post passes through thewound; after the subfascial extension passes through the wound, movingthe post such that the subfascial extension is in contact with asubfascial surface around the wound; and moving the rod towards thewound such that: the suprafascial rivet head is pushed by the rodtowards the subfascial rivet head, the subfascial rivet head engageswithin the suprafascial rivet head, the compressible column iscompressed within the wound, and a suprafascial extension coupled to thesuprafascial rivet head is in contact with a suprafascial surface aroundthe wound.
 16. The method of claim 15, wherein engaging the subfascialrivet head within the suprafascial rivet head includes engaging annualgroves of the subfascial rivet head with annual grooves of thesuprafascial rivet head, the method further comprising: interlockingsubfascial and suprafascial portions of the wound plug; and deployingthe wound plug.
 17. The method of claim 16, wherein deploying the woundplug includes: deploying the subfascial rivet concurrently withdeploying of an interior portion the wound plug; and deploying thesuprafascial rivet head concurrently with deploying a superior portionof the wound plug.
 18. The method of claim 15, further comprising:dispersing a material from the compressible column.
 19. The method ofclaim 18, further comprising: temporarily anchoring the first end of thepost to an electrospun network within layers of a subfascial biohybridscaffold; and twisting, torqueing, pulling, or snapping the post. 20.The method of claim 15, further comprising: creating an audible soundwhen the subfascial rivet head is located below the fascia surroundingthe wound.